I 摘要 J公司药物警戒管理改进研究 药物具有两重性，一方面可以防病治病, 促进患者生理机能的恢复, 另一方 面也可能引起危害人体的药物不良反应，给社会、家庭造成沉重的经济负担。从 1974年法国科学家首次提出药物警戒概念至今已有40多年，药物警戒的主要工 作也从起初的药物不良反应监测转变成对药物全生命周期的风险监测和管理的 过程。随着经济全球化和医药产品全球贸易的日益发展，跨国制药企业的业务在 全球范围内稳步扩张的同时也越来越注重产品的研发与创新，公司内部业务活动 和研发活动需要的药物警戒支持也逐渐增多。同时，由于全球各个国家/地区的 药物警戒监管法规也日趋严格与多样化，外部监管部门对制药公司的药物警戒工 作提出了新的要求。对于跨国制药企业而言，维持一个稳健、高效、合作的全球 药物警戒体系使之能满足内外部日益增长的需求，已经变成了一个不可忽视的重 要命题。 本文通过对J公司药物警戒管理工作的研究，运用案例分析、文献研究和调 查研究的等方法，对J公司药物警戒工作的内外部环境进行深入了解，并对J公 司药物警戒管理相关的组织架构、培训体系、数据管理、流程管理、供应商管理 五大方面的现状进行分析，在这些方面发现的问题有：首先，全球药物警戒职能 相关的团队架构比较复杂，信息需要在各个药物警戒团队之间不断流转，整个药 物警戒团队沟通成本较高，运行效率不高，对于外部多变的监管环境的反应速度 较缓慢；其次，存在多个培训系统且管理存在问题、培训形式单一、培训课程设 计不合理、培训机制不健全；第三，全球药物警戒数据库的功能落后，无法满足 内外部“客户”需求，且对于药物警戒数据管理的质量控制措施冗余；第四，流 程文件过多，不方便应用，各级业务流程管理员职能薄弱或无专职人员管理相关 业务流程文件，内部的合规监测和内部审计未能完全发挥作用；最后，公司业务 部门对于药物警戒供应商管理的理解不够，药物警戒在供应商全生命周期管理中 的参与不够。针对发现的问题结合基于全面质量管理和流程管理的相关理论知识， 对这五大方面进行改进研究，确定改进方案的实施计划、实施计划需要的保障措 施并分析实施后预计的效果，最终提升公司药物警戒的整体水平、提高药物警戒 团队的工作效率、增强药物警戒团队人员的职业认同感、提高企业应对药物安全 吉林大学硕士学位论文 II 问题的能力，最终达到保护患者安全的终极目标。 通过本文研究，对跨国制药企业全球药物警戒管理可能普遍存在的问题提出 了优化方案，希望能够给相关制药企业在构建和优化药物警戒管理体系提供借鉴 和参考。 关键字： 全面质量管理，流程管理，药物警戒，药物安全 ABSTRACT III ABSTRACT Improvement of Pharmacovigilance Management in J Company Drugs have a dual nature. On the one hand, drugs can prevent and treat diseases, and promote the recovery of patients' physiological functions. On the other hand, drugs can also bring adverse drug reactions to patients and cause a heavy economic burden on society and their families. It has been more than 40 years since the concept of Pharmacovigilance (PV) was first proposed by a French scientist in 1974. The main work of PV has also changed. It is no longer the monitoring of adverse drug reactions, but the process of risk monitoring and management during the drug's entire life cycle. With the economic globalization and the growing development of global trade in pharmaceutical products, the business of multinational pharmaceutical companies has steadily expanded around the world, while paying more attention to product development and innovation. The company's internal business activities and Research and Development activities gradually increased their need to PV support. At the same time, as PV regulations in various countries / regions around the world have become stricter and more diverse, and external regulators have put forward new requirements for pharmaceutical companies' PV work. For multinational pharmaceutical companies, maintaining a robust, efficient, and cooperative global PV system to enable them to meet growing internal and external demands has become an important proposition that cannot be ignored. This article studies J company's PV management, by using case analysis, literature research, and investigation and research methods. And the internal and external environment of J Company's PV work have been investigated. In addition, the current status of the following five major areas has been analyzed: organizational structure, training system, data management, process management, and supplier management of J company's PV management work. Issues found in these areas are as following: firstly, due to the team structure of the global PV function is complex, information needs to be continuously transferred between the various PV teams, which causing a high communication cost within the entire PV team. Leading to a fact that a low operation 吉林大学硕士学位论文 IV efficiency and a low response speed to the changing external regulatory environment. Secondly, there are multiple training systems and management problems, such as monotonous form of training, unreasonable training course design, and imperfect training mechanism. Thirdly, the function of the global PV database is lagging and cannot meet the needs of internal and external "customers", and the quality control measures for PV data management are redundant. Fourthly, there are too many process files which are inconvenient to apply, and the functions of business process administrators at all levels are weak or there are no full-time business process administrators in some level. Internal compliance monitoring and internal audit are not fully functioning. Last but not least, the understanding of business departments on PV supplier management needs improvement and PV department’s involvement in the supplier lifecycle management is not enough. Based on the relevant theoretical knowledge of Total Quality Management and Process Management, the article carries out the improvement research for the issues found in these five aspects, determine the implementation plan, guarantee measures of the improvement plan, and further analyze the expected effects after implementation, to ultimately improve the overall quality of J company's PV work, the efficiency and professional identity of the PV team, improve the company's ability to respond to drug safety issues, and achieve the ultimate goal of protecting patient safety. This article provides an optimization plan for global PV management of multinational pharmaceutical companies, also hoping to act as reference for set-up and optimization of PV management systems in relevant pharmaceutical companies. Key words: Total Quality Management, Process Management, Pharmacovigilance, Drug Safety 目 录 V 目 录 第1章 绪论 .................................................................................................................................... 1 1.1 选题的背景和意义........................................................................................................... 1 1.2 研究的目的和主要内容................................................................................................... 3 1.3 研究的主要方法............................................................................................................... 4 1.4 论文整体结构................................................................................................................... 5 第2章 相关理论基础 .................................................................................................................... 7 2.1 药物警戒基本理论........................................................................................................... 7 2.1.1 药物警戒的定义 ................................................................................................... 7 2.1.2 药物警戒的工作内容和目标 ............................................................................... 8 2.2 全面质量管理理论......................................................................................................... 10 2.2.1 全面质量管理的基本概念 ................................................................................. 10 2.2.2 全面质量管理的核心内容 ................................................................................. 11 2.2.3 全面质量管理的基本工作程序：PDCA循环 .................................................. 12 2.2.3 全面质量管理的五大要素